On April 28, 2015 Invivoscribe Technologies reported that it has signed an agreement with Astellas Pharma to develop a companion diagnostic for an investigational drug (Press release, Invivoscribe Technologies, APR 28, 2015, View Source [SID1234550141]).

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Under the terms of the agreement, Invivoscribe will develop and commercialize a companion diagnostic based on the FLT3 tyrosine kinase gene and use the international harmonized signal ration test to stratify and enroll acute myeloid leukemia (AML) patients for Astellas clinical trials of the drug candidate ASP2215 in the US, Europe, Japan, and other countries.

San Diego-based Invivoscribe will receive an upfront payment; reimbursements for development, regulatory, and commercialization costs; and milestone payments for reaching certain goals. The firm will be responsible for all development, commercialization, and regulatory activity in the US, Europe, and Japan.

FLT3 mutation status is typically determined for AML patients as a part of the standard of care, the firm said in a statement.

"We are looking forward to this expanded use of our harmonized companion diagnostic around the FLT3 biomarker," Invivoscribe Chairman and CEO Jeffrey Miller said in a statement. "This signal ratio assay is an internationally recognized test for identifying patients with FLT3 mutations and an important tool for stratifying cytogenetically normal AML."

In 2011, Invivoscribe signed a companion diagnostics partnership with Novartis based on the FLT3 gene for AML.

On April 27, 2015 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") reported that the independent Data Safety Monitoring Board ("DSMB") for the pivotal Phase 3 ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) study with zoptarelin doxorubicin in women with advanced, recurrent or metastatic endometrial cancer, has completed a pre specified first interim futility analysis (Press release, AEterna Zentaris, APR 27, 2015, View Source;q=655 [SID:1234506576]). The DSMB has recommended that the Phase 3 study continue as planned.

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David Dodd, Chairman and CEO of Aeterna Zentaris, commented, "We are very pleased with this positive recommendation from the DSMB on our ZoptEC Phase 3 trial in endometrial cancer, and I would like to thank everyone involved in this project for their unwavering dedication. With approximately 90 % of patients enrolled at this time, we are well on our way of completing patient recruitment ahead of the anticipated timeline. We believe that zoptarelin doxorubicin has the potential to become the first FDA approved medical therapy for advanced, recurrent endometrial cancer This could result in its rapid adoption as a novel core therapy for patient treatment & management, and therefore, could represent a significant market opportunity for the Company. Moving forward, we are continuing to develop our commercialization plans regarding zoptarelin doxorubicin in this indication, including establishing additional partnerships in territories that won’t be pursued by Aeterna Zentaris. In addition, contingent on the success of the ZoptEC program, we have additional areas of interest for further therapeutic development, including ovarian, prostate and triple negative breast cancer. Our commitment is to ensure that patients and their physicians have such therapies that can potentially improve and extend the quality of lives."

The ZoptEC Phase 3 trial is an open-label, randomized-controlled study, comparing the efficacy and safety of zoptarelin doxorubicin, a hybrid molecule composed of a synthetic peptide carrier and a well known chemotherapy agent, doxorubicin, to doxorubicin alone. It is being conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration ("FDA"). Patients are centrally randomized in a 1:1 ratio and receive either zoptarelin doxorubicin (267 mg/m2) or doxorubicin (60 mg/m2) intravenously, every 3 weeks and for up to 9 cycles. Response will be evaluated every 3 cycles during treatment, thereafter, every 12 weeks until progression. All patients will be followed for survival as the primary efficacy endpoint ("EP"). Secondary EPs include progression-free survival, objective response-rate, and clinical benefit rate.

At this time, sites initiation has been completed with over 120 sites in operation in North America, Europe and Israel. More than 465 patients out of an expected total of 500 have been recruited. A second interim analysis will be conducted according to protocol at approximately 192 events, with the final analysis planned at an anticipated 384 events.

For more information on this trial, please consult (ClinicalTrials.gov Identifier: NCT01767155; EudraCT No: 2012-005546-38; ZoptEC: Zoptarelin doxorubicin in endometrial cancer).

About Zoptarelin Doxorubicin

Zoptarelin doxorubicin represents a new targeting concept in oncology using a hybrid molecule composed of a synthetic peptide carrier and a well-known chemotherapy agent, doxorubicin. Zoptarelin doxorubicin is the first intravenous drug in advanced clinical development that directs the chemotherapy agent specifically to LHRH-receptor expressing tumors, which could result in a more targeted treatment with less damage to healthy tissue. The Company is currently conducting a ZoptEC (Zoptarelin doxorubicin in Endometrial Cancer) Phase 3 trial in women with advanced, recurrent or metastatic endometrial cancer, while zoptarelin doxorubicin is also in an investigator-initiated Phase 2 trial in prostate cancer. Aeterna Zentaris owns the worldwide rights to this compound except in China (including Hong Kong and Macau) where rights have been out-licensed to Sinopharm A-Think Pharmaceuticals, a subsidiary of Sinopharm, the largest medical and healthcare group in China and on Fortune’s Global 500 list. On April 16, 2015, the Company announced the filing of a patent application intended to strengthen the exclusivity of zoptarelin doxorubicin through a unique, significantly lower cost in the manufacturing process.

About Endometrial Cancer

Endometrial cancer is the most common gynecologic malignancy in developed countries and develops when abnormal cells amass to form a tumor in the lining of the uterus. It largely affects women over the age of 50 with a higher prevalence in Caucasians and a higher mortality rate among African Americans. According to the American Cancer Society, there will be more than 50,000 new cases of endometrial cancer in the U.S. alone in 2015, with about 20% of recurring disease.

Amgen has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Amgen, APR 27, 2015, View Source [SID1234503189]).

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On April 27, 2015 Alligator Bioscience AB reported that the first patient was dosed early last week in the recently initiated phase 1 clinical trial of the immuno-oncology antibody ADC-1013 (Press release, Alligator Bioscience, APR 27, 2015, View Source [SID1234538694]). ADC-1013 is an agonistic fully human monoclonal antibody targeting CD40, an immune-stimulatory receptor found on antigen-presenting cells such as dendritic cells.

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The clinical phase 1 trial is a first-in-human trial for patients with advanced solid tumor disease. Dr. Per Norlén, Chief Medical Officer at Alligator Bioscience, commented that "we are very pleased to confirm that dosing of the first patient was successful. The interest for participation in our first-in-human trial has been massive, allowing dosing of the first patient at Uppsala University Hospital, Sweden, within 3 weeks of starting recruitment. ADC-1013 was well tolerated and not associated with any significant adverse reactions. Currently we have opened 2 clinical sites, and expect all 5 sites to be active shortly."

As mentioned in a previous press release April 7, the study will enroll up to 40 patients during the dose escalation and expansion phases at five centers in the United Kingdom, Denmark and Sweden.

On April 24, 2015 ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops novel anticancer therapeutics using its ADC technology, today reported financial results for the three-month period ended March 31, 2015 – the third quarter of the Company’s 2015 fiscal year. ImmunoGen also provided an update on its product pipeline and financial guidance (Press release, ImmunoGen, APR 24, 2015, View Source [SID1234503177]).

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"We are executing against our product development plan and recently strengthened our financial resources to support these programs," commented Daniel Junius, President and CEO. "The clinical findings with mirvetuximab soravtansine to date are encouraging, and we look forward to their presentation at ASCO (Free ASCO Whitepaper) next month. Based on these data and the medical need, we are expanding the compound’s clinical program and implementing preparations to support an accelerated development pathway."

Mr. Junius continued, "We are also expanding the development program for our CD37-targeting ADC, IMGN529, to include assessment in combination with rituximab for non-Hodgkin lymphoma as well as evaluation as a single agent for diffuse large B-cell lymphoma and chronic lymphocytic leukemia. Updates on other hematology programs include that we are developing our plans for the CD19-targeting ADC, coltuximab ravtansine, for B-cell malignancies that we recently regained from Sanofi, we remain on track for IND submission later this year with IMGN779 for acute myeloid leukemia, and Biotest continues to make important progress with their CD138-targeting ADC for multiple myeloma and certain solid tumors."

Pipeline Updates

Mirvetuximab soravtansine, a potential new therapy for many cases of ovarian cancer as well as for endometrial cancer and other solid tumors that highly express folate receptor α (FRα); wholly owned by ImmunoGen.

This ADC now has received orphan designation in ovarian cancer in the EU as well as in the US.
Initial findings with mirvetuximab soravtansine – used as a single agent – to treat FRα-positive platinum-resistant ovarian cancer will be presented at the 2015 ASCO (Free ASCO Whitepaper) Annual Meeting. The data are from a disease-specific Phase 1 cohort. ImmunoGen plans to initiate a Phase 2 trial in this indication by the end of 2015 that could potentially support an accelerated registration pathway.
ImmunoGen also plans to initiate in 2H2015 assessment of mirvetuximab soravtansine used in combination regimens for ovarian cancer.
Assessment of mirvetuximab soravtansine for the treatment of FRα-positive relapsed/ refractory (R/R) endometrial cancer is ongoing. ImmunoGen is preparing to also assess it for FRα-positive R/R non-small cell lung cancer.
In addition to the every three week dosing schedule being used in the disease-specific testing underway, dose-finding with a weekly dosing regimen is advancing. The findings to date also have been accepted for presentation at ASCO (Free ASCO Whitepaper).

IMGN529, a potential new treatment for B-cell malignancies; wholly owned by ImmunoGen.

Once the recommended Phase 2 dose is established, ImmunoGen plans to evaluate it specifically for the treatment of R/R diffuse large B-cell lymphomas (DLBCL) and chronic lymphocytic leukemia.
Preclinical findings with IMGN529 used with rituximab (Rituxan) will be reported at the International Conference on Malignant Lymphoma in Lugano in June 2015. ImmunoGen is planning to initiate a clinical trial to assess the combination.
The next IMGN529 clinical data presentation(s) are targeted for the ASH (Free ASH Whitepaper) annual meeting in December.

Indatuximab ravtansine (BT-062), a CD138-targeting ADC for multiple myeloma and certain solid tumors; wholly owned by Biotest; ImmunoGen holds rights to opt-in with Biotest on joint US development and commercialization.

Phase 2 trial ongoing in multiple myeloma; Phase 1 trial ongoing in triple-negative breast cancer and metastatic urinary bladder cancer.

Coltuximab ravtansine (SAR3419), a potential therapy for DLBCL and other B-cell malignancies; demonstrated encouraging activity in the treatment of R/R DLBCL in STARLYTE Phase 2 trial presented at ASCO (Free ASCO Whitepaper) 2014 and selected for Best of ASCO (Free ASCO Whitepaper).

ImmunoGen recently regained the rights to this promising ADC from Sanofi.

IMGN779, CD33-targeting ADC utilizing one of ImmunoGen’s DNA-acting payload agents; a potential treatment for acute myeloid leukemia and myelodysplastic syndrome; wholly owned by ImmunoGen.

Remains on track for IND submission in 2H2015.

IMGN289, EGFR-targeting ADC, wholly owned by ImmunoGen.

The Company has stopped Phase 1 testing and returned the program to research.

Genentech/Roche’s ado-trastuzumab emtansine (Kadcyla), which uses ImmunoGen’s ADC technology.

Approved in the US, Europe, and other geographies based on the results from the EMILIA Phase 3 trial; in development by Roche for a number of indications, with data from the MARIANNE Phase 3 trial to be presented at ASCO (Free ASCO Whitepaper).
ImmunoGen recently reported a monetization transaction pertaining to the royalties earned on Kadcyla sales.

Financial Results

For the Company’s quarter ended March 31, 2015 (3QFY2015), ImmunoGen reported a net loss of $21.6 million, or $0.25 per basic and diluted share, compared to a net loss of $37.5 million, or $0.44 per basic and diluted share, for the same quarter last year (3QFY2014).

Revenues for 3QFY2015 were $11.4 million, compared to $6.9 million for 3QFY2014. They include $5.1 million of license and milestone fees, principally from a $5 million cash milestone payment earned from Novartis with the initiation of Phase 1 testing of its product candidate, LOP628. They also include $5.1 million of royalty payments received from Roche in March 2015 for sales of Kadcyla during the three-month period ended December 31, 2014. The royalty transaction recently announced impacts royalties earned on Kadcyla sales starting January 1, 2015. Revenues for 3QFY2015 also include $0.7 million of clinical materials revenue and $0.5 million of research and development support fees. The level of research support and the number of batches of clinical materials produced and released to partners varies on a quarter-to-quarter basis.

Operating expenses in 3QFY2015 were $32.7 million, compared to $44.3 million in 3QFY2014, and consist of research and development expenses of $25.7 million and general and administrative expenses of $7.0 million. The prior year period included a $12.8 million non-cash charge recorded to research and development expense related to a collaboration agreement executed with CytomX.

ImmunoGen had approximately $111.8 million in cash and cash equivalents as of March 31, 2015, – inclusive of a $20 million upfront payment received from Takeda – compared with $142.3 million as of June 30, 2014. Cash used in operations was $27.4 million in the first nine months of FY2015 and capital expenditures were $4.5 million.

Financial Guidance for Fiscal Year 2015

ImmunoGen has updated its guidance for its fiscal year ending June 30, 2015. The Company’s guidance for its net loss is unchanged, and expected to be between $60 million and $65 million. Expected revenues are now projected to be between $85 million and $95 million, compared with previous guidance of between $100 million and $105 million, due to changes in the expected timing of partner milestone events. Expected operating expenses are now projected to be between $145 million and $150 million, compared with previous guidance of between $160 million and $165 million.

ImmunoGen now projects cash and cash equivalents at June 30, 2015 to be between $265 million and $275 million, compared to previous guidance of $75 million to $85 million. This change principally reflects the Kadcyla royalty monetization transaction announced in March 2015. The Company’s guidance for cash used in operations and capital expenditures remains unchanged from that issued on January 2015. These are projected to be between $55 million and $60 million and between $7 million and $9 million, respectively.